Moleculin to Highlight its Ongoing Phase 3 Acute Myeloid Leukemia "MIRACLE" Clinical Trial at the 14th Annual Acute Leukemia Meeting
Moleculin will present preliminary data from its Phase 3 MIRACLE trial evaluating Annamycin (AnnAraC) in relapsed/refractory acute myeloid leukemia (AML) patients.
Moleculin Biotech, Inc. announced that it will present at the 14th Annual Acute Leukemia Meeting information on its Phase 3 MIRACLE trial—an adaptive, randomized, double‑blind, placebo‑controlled study of Annamycin combined with cytarabine (AnnAraC)—in adults with relapsed or refractory AML. The trial, which has Fast Track and Orphan Drug status from the FDA and EMA, is enrolling patients in the US, Europe and the Middle East (NCT06788756). The company reports that the study follows a successful Phase 1B/2 program and is poised for regulatory approval pending data presentation.
The MIRACLE trial addresses an unmet need in relapsed/refractory AML, a disease with poor prognosis and limited treatment options. Successful outcomes could establish a first‑line, non‑cardiotoxic anthracycline plus cytarabine therapy for this population.
Evidence level: Állatkísérletes. Állatmodellben vizsgálták.
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